This invention relates to a manually operable flexible container system which includes means to intermix a medicament and a diluent entirely within the container by physical manipulation from outside the container. More particularly, this invention relates to an additive mixing system for use in the infusion of I.V. fluids. The mixing system is made part of a flexible storage container commonly used to hold a standard liquid diluent such as normal saline solution, dextrose or water. The additive is commonly a powdered or liquid medicament which is compatible with the liquid diluent for treatment purposes but cannot be stored in solution with the liquid diluent for long periods of time.
Container devices which provide separate spaces in a single unit for separately enclosing different materials in such a way that they may be intermixed at time of use are described in U.S. Pat. No. 2,176,923 to Nitardy, U.S. Pat. No. 3,290,017 to Davies, et al., and U.S. Pat. No. 3,532,254 to Burke, et al. These container devices are deficient because they do not maintain an effective fluid-tight seal or moisture barrier between the two spaces containing the incompatible materials which are eventually to be intermixed. This deficiency is caused by the various barriers between the storage spaces within the container not adequately withstanding the normal rigors of packaging, handling and shipping. If the fluid-tight seal or moisture barrier between the storage spaces is in any way ruptured, premature mixing of the materials may occur which then renders the materials ineffective for eventual use. Additionally, for containers used in health care situations, sterility of the materials to be mixed and the mixing system itself must be strictly maintained. If more complexity is added to the container to assure a fluid-tight seal or moisture barrier between the storage spaces, sequential sterilization of the mixing system during the various stages of manufacture may become difficult and expensive. One solution is to manufacture and fill the container in a sterile environment. Such manufacture however, is expensive. Consequently, the need exists in the art to provide a container device which will provide a fluid-tight seal and an impervious moisture barrier between a powdered medicament and a liquid diluent that can both be easily sterilized during manufacture and conveniently used as part of an I.V. administration system.
The prior art does not show the use of a vial with a removable stopper or stoppers within a flexible container to maintain a fluid-tight and moisture-proof barrier in a sterile environment before fluid communication between the contents of the vial and the liquid diluent is established.
It is therefore an advantage of the present invention to provide a manually operable, flexible container and mixing system, not subject to the aforementioned limitations and disadvantages of the prior art.
It is another advantage of the present invention to provide a manually operable flexible container that is substantially chemically inert, nonbreakable, lightweight, and exceedingly compact.
It is still another advantage of the present container and mixing system to provide a manually operable, flexible container that is easily activated, and does not require special sealing gaskets or "O" rings. Other advantages of the present invention will become more apparent in the following description.